BridgeMD
New treatment option for Anatomic Stage IV Breast Cancer AJCC v8
Official title Mobile Health for Adherence in Breast Cancer Patients
ClinicalTrials.gov ID: NCT06112613
What this study is testing
- What it's testing
- This clinical trial compares the use of the connected customized treatment platform (CONCURxP), consisting of using a medication monitoring device called WiseBag along with text message reminders for missed or extra medication events, to enhanced usual care (EUC), where patients only use the WiseBag, to monitor medication adherence in patients with metastatic breast cancer who are taking a CKD4/6 inhibitor. To ensure CDK4/6 inhibitors achieve their full clinical benefit, patients need to take them as prescribed, following a complex treatment schedule.
- Time commitment: about 12 months
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older. Healthy volunteers may be eligible.
You may be able to join if
- NON-PATIENT: Participants must be an oncology healthcare provider (i.e., oncologist, advanced practice provider, or oncology nurse)
- NON-PATIENT: Participants must have taken care of at least one patient assigned by chance to Arm B (CONCURxP) who had less than 85% adherence rate at...
- NON-PATIENT: Participant must speak English
- NON-PATIENT: Participant must be employed at an National Cancer Institute Community Oncology Research Program (NCORP) site for at least 6 months
- NON-PATIENT: Participant must be able to provide informed consent to participate in this study
See the full eligibility criteria
- NON-PATIENT: Participants must be an oncology healthcare provider (i.e., oncologist, advanced practice provider, or oncology nurse)
- NON-PATIENT: Participants must have taken care of at least one patient assigned by chance to Arm B (CONCURxP) who had less than 85% adherence rate at 12 months as measured by the WiseBag
- NON-PATIENT: Participant must speak English
- NON-PATIENT: Participant must be employed at an National Cancer Institute Community Oncology Research Program (NCORP) site for at least 6 months
- NON-PATIENT: Participant must be able to provide informed consent to participate in this study
- PATIENT STEP 0: Patient must be \>= 18 years of age
- PATIENT STEP 0: Patient must be fluent in written and spoken English OR patient must be fluent in written and spoken Spanish
- PATIENT STEP 0: Patient must present with new or established pathologically proven hormone receptor (HR)+ HER2- metastatic breast cancer at the time of Step 0
- PATIENT STEP 0: Patient must have initiated any of the CKD4/6 inhibitors (palbociclib or Ibrance, ribociclib or Kisqali, abemaciclib or Verzenio) within 30 days prior to consenting to Step 0 or have received a...
- NOTE: Patients who have been treated previously with anticancer treatments other than CDK4/6 inhibitors are eligible
- NOTE: CDK4/6 inhibitors must be provided/supplied as a single agent blister pack. If the medication is supplied as capsules in a pill bottle (e.g., Ibrance capsules), patient is not eligible
- NOTE: Ribociclib (Kisqali) and abemaciclib (Verzenio) are only available in blister packs. Palbociclib (Ibrance) is the only CDK4/6 inhibitor that might be available in a capsule formulation. However, this is an...
- PATIENT STEP 0: Patients must not have been previously treated with any of the following CDK4/6 inhibitors: Palbociclib or Ibrance, ribociclib or Kisqali, and abemaciclib or Verzenio
- PATIENT STEP 0: Patients must not already be enrolled in a therapeutic clinical trial that monitors CDK4/6 inhibitors
- PATIENT STEP 0: Patient must confirm that they intend to receive their care or monitoring at an NCORP site
- PATIENT STEP 0: Patient must have a personal mobile phone in which they are able and willing to send and receive text messages
- NOTE: The restriction to those with mobile phone access with text messaging is based on the primary intention of the study which involves the use of text messaging to improve adherence
- PATIENT STEP 0: Patient must have an email address
- NOTE: The restriction to those with an email address is based on the primary intention of the study which involves patients responding to questions regarding their reasons for non-adherence after every missed dose to...
- PATIENT STEP 0: Patient must have the ability to understand and the willingness to sign a written informed consent document
- NOTE: Patients with impaired decision-making capacity (IDMC) who have a legally authorized representative (LAR) or caregiver and/or family member available are not eligible
- PATIENT STEP 0: Patient must not have an Eastern Cooperative Oncology Group (ECOG) performance status \>= 3 OR patient must not be deemed medically unable to participate in the study by the study investigators or an...
- PATIENT STEP 0: Patient must not be enrolled in other trials offering financial assistance
- NOTE: Gift cards for survey completion, parking passes, or free medication provided as part of therapeutic trials are not considered financial assistance
- PATIENT STEP 1: Patient must meet all the eligibility criteria for Step 0
- PATIENT STEP 1: Patient must have signed a written informed consent form
- PATIENT STEP 1: Patient must have completed baseline survey within 30 days of the date of Step 0 Registration
- PATIENT STEP 1: Patients must have initiated their CDK 4/6 inhibitors within 30 days of the date of Step 0 registration
The study team makes the final eligibility decision.
Where it's taking place
- Fairbanks, Alaska, United States
- Kingman, Arizona, United States
- Phoenix, Arizona, United States
- Fort Smith, Arkansas, United States
- Jonesboro, Arkansas, United States
- Little Rock, Arkansas, United States
- Anaheim, California, United States
- Arroyo Grande, California, United States
- Baldwin Park, California, United States
- Bellflower, California, United States
- Carmichael, California, United States
- Elk Grove, California, United States
- Fontana, California, United States
- Harbor City, California, United States
- Irvine, California, United States
- Los Angeles, California, United States
- Martinez, California, United States
- Merced, California, United States
- Ontario, California, United States
- Orange, California, United States
+ 323 more site(s).
Compensation & support
A stipend or compensation may be offered.
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 12 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Fairbanks, Alaska, United States; Kingman, Arizona, United States; Phoenix, Arizona, United States; Fort Smith, Arkansas, United States; Jonesboro, Arkansas, United States; Little Rock, Arkansas, United States and 337 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.